Clinical Trial: Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia

Brief Summary: This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Detailed Summary: This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).
Sponsor: Sanford Research

Current Primary Outcome: The primary endpoint will be the effect of treatment on lipoprotein binding to target cells. [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Performance of VLDL as a substrate for lipolysis. [ Time Frame: one year ]
  • Plasma LpL mass and activity. [ Time Frame: one year ]
  • VLDL, LDL, HDL oxylipin and fatty acid content [ Time Frame: one year ]


Original Secondary Outcome: Same as current

Information By: Sanford Research

Dates:
Date Received: August 14, 2009
Date Started: September 2009
Date Completion:
Last Updated: November 17, 2014
Last Verified: November 2014